MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133605IL

Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture of the complaint issue was provided by the customer.Evaluation is still in progress.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Note: the ¿suspected medical device¿ reported in this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under p030031/s053.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the sterilized pouch where the device is located was torn compromising sterility.It was reported that before the operation, the sterilization package was broken after the carton was opened.A second device was used to complete the operation.There was no adverse event reported on patient.Device was not used in patient.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the sterilized pouch where the device is located was torn compromising sterility.It was reported that before the operation, the sterilization package was broken after the carton was opened.A second device was used to complete the operation.There was no adverse event reported on patient.Device was not used in patient.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection of the returned device was performed following bwi procedures.Pictures were also provided by the customer to aid in the product investigation.According to pictures provided by the customer, a hole was observed on the pouch of the device.A visual analysis in the lab of the returned product also revealed damage in the packaging; which could compromise the sterility of the catheter.All units are inspected prior leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.The damage reported, could be related to the process of storing, packaging or shipping of the device, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 24-may-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16946956
• MDR Text Key: 315489670
• Report Number: 2029046-2023-01054
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2023
• Device Catalogue Number: D133605IL
• Device Lot Number: 30950292M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THMCL SMARTTOUCH,TC,F,C3,OBL.